News

FDA Approves SHIRE’S Xiidra for Dry Eye Disease

The US Food and Drug Administration (FDA) has approved Shire’s Xiidra (lifitegrast ophthalmic solution) 5%, a prescription eye drop solution indicated for the signs and symptoms of dry eye disease (DED) in adults. Xiidra is the only prescription eye drop indicated for the treatment of both the signs and symptoms of this condition, and it is the first treatment to be approved for DED in more than a decade, Shire reports. Shire expects to launch the product in the United States in the third quarter of 2016. 

Xiidra is dosed twice per day, approximately 12 hours apart, in each eye. The safety and efficacy of the drug was studied in 1,181 patients (1,067 of whom received lifitegrast 5%) in four placebo-controlled, 12-week trials. The most common adverse reactions reported in 5% to 25% of patients were instillation site irritation, altered taste sensation, and reduced visual acuity.

 


 

Allergan Applies for FDA Approval of Oculeve

Allergan filed an FDA de novo application for the Oculeve Intranasal Tear Neurostimulator device, according to a news release. Allergan reported that two pivotal trials showed that the handheld stimulator temporarily increased tear production in patients with DED due to decreased tear production.

According to the FDA, the de novo process provides a pathway for medical devices for which general or special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

 


 

FDA Approves CyPass Micro-Stent System

The FDA has approved Alcon’s CyPass Micro-Stent System for use in combination with cataract surgery. The device is designed for placement in the angle of the eye, with the proximal end extending into the anterior chamber and the distal end residing in the supraciliary space. This allows outflow of fluid from the anterior chamber through the distal end of the device into the supraciliary and suprachoroidal spaces.

In a study of 505 patients diagnosed with primary open-angle glaucoma, 72.5% of patients randomized to receive the device and cataract surgery achieved a significantly lower diurnal intraocular pressure compared with 58% of patients who had cataract surgery alone. Adverse events included rare instances of hypotony maculopathy, peripheral anterior choroidal effusion, IOL subluxation, and corneal compromise. The most common safety concerns were related to bleeding, inflammation, and damage to angle tissue (ie, iridodialysis, larger than expected cyclodialysis cleft, ciliary body edema). Some patients experienced device malposition, device movement, and tube obstruction.

 


 

Avedro Receives New Indication for CXL Platform

The FDA has approved Avedro’s corneal collagen cross-linking (CXL) platform for the treatment of corneal ectasia following refractive surgery, according to a news release. The approval marks the second indication for Avedro’s photo-enhancers Photrexa Viscous and Photrexa, used in conjunction with the KXL System. Avedro’s platform received an initial indication for the treatment of progressive keratoconus in April, and it is the only CXL therapy approved in the United States, Avedro reports.

In corneal ectasia patients enrolled in the clinical studies, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelial defect, corneal striae, dry eye, ocular pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision. In 6% of corneal ectasia patients, corneal opacity continued to be observed at 12 months.

 


 

FDA Approves Topcon’s 3D OCT-1 Maestro

The 3D OCT-1 Maestro (Topcon) has received FDA approval and is now available for sale in the United States, according to a news release. The device combines a high-resolution, color, nonmydriatic retinal camera with spectral-domain optical coherence tomography. It features a rotating touch panel and automated alignment, focus, and capture. PinPoint Registration properly indicates the location of the optical coherence tomography image within the fundus image. A 12-mm by 9-mm scan with automated segmentation provides measurements and topographical maps of the optic nerve and macula.

 


 

CREST Study Shows That Carotenoids Improve Vision

Supplemental carotenoids can improve already healthy vision, according to a study by the Macular Pigment Research Group at the Nutrition Research Centre Ireland, part of the School of Health Sciences at Waterford Institute of Technology, Waterford.

In the Central Retinal Enrichment Supplementation Trials (CREST), John M. Nolan, PhD, and colleagues investigated the potential benefits of lutein, zeaxanthin, and meso-zeaxanthin supplementation in individuals whose eyes lack sufficient concentrations of macular pigment. CREST was a parallel, double-masked, placebo-controlled, block-randomized study that enrolled 105 subjects. During a 12-month period, 53 subjects received a daily formula of naturally occurring carotenoids (10 g lutein, 10 g meso-zeaxanthin, 2 g zeaxanthin), and 52 subjects received a placebo. The authors concluded that supplementation of macular carotenoids (lutein, zeaxanthin, and meso-zeaxanthin) can increase macular pigment and enhance visual function, particularly contrast sensitivity.

The study was funded by the European Research Council.

 


 

Clinical Alert on HORV Association With Intraocular Vancomycin

The American Society of Cataract and Refractive Surgery and the American Society of Retina Specialists have issued a clinical alert and formed a joint task force to analyze the prevalence, potential etiology, treatment, and outcomes of hemorrhagic occlusive retinal vasculitis (HORV) associated with intraocular surgery, according to news release.

The American Society of Cataract and Refractive Surgery and the American Society of Retina Specialists have identified 22 HORV cases: 14 were bilateral, and eight were unilateral, for a total of 36 eyes. Although reporting and data collection are ongoing, preliminary findings from these 22 cases warrant this special clinical alert because of their potential impact on patients’ safety, the alert stated.

HORV can occur following any intraocular procedure (usually cataract surgery), with a mean onset of symptoms 8 days after the procedure. The cause of HORV is not yet proven, but there is a strong association with the use of intraocular vancomycin, the groups reported. As of now, there has not been an association with one formulation or one manufacturer. The full clinical alert is available at http://www.ascrs.org/node/26101. n